UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009086 |
|---|---|
| Receipt number | R000010278 |
| Scientific Title | Cohort study evaluating efficacy of bevacizumab plus paclitaxel in patients with HER2-negative inoperable or metastatic breast cancer(JBCRG-C05) |
| Date of disclosure of the study information | 2012/10/12 |
| Last modified on | 2021/08/18 09:27:07 |
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Basic information
Public title
Cohort study evaluating efficacy of bevacizumab plus paclitaxel in patients with HER2-negative inoperable or metastatic breast cancer(JBCRG-C05)
Acronym
JBCRG-C05(B-SHARE)
Scientific Title
Cohort study evaluating efficacy of bevacizumab plus paclitaxel in patients with HER2-negative inoperable or metastatic breast cancer(JBCRG-C05)
Scientific Title:Acronym
JBCRG-C05(B-SHARE)
Region
| Japan |
Condition
Condition
HER2-negative inoperable or metastatic breast cancer
Classification by specialty
| Hematology and clinical oncology | Surgery in general | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the efficacy and safety of bevacizumab combined with paclitaxel as first or second line chemotherapy in clinical practice in HER2 negative inoperable or metastatic breast cancer patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Overall Survival: OS
Key secondary outcomes
Response Rate: RR
Progression Free Survival: PFS
Safety
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1. Agreed to receive combination of bevacizumab and paclitaxel
2. Patients have been confirmed with breast cancer histologically or cytologically
3. Histologically confirmed invasive breast cancer by biopsy
4. HER2 negative; FISH negative or IHC 2+ or less (need to check negative status by FISH if IHC score is 2+)
5. Expression status of ER and PgR has been confirmed in immunohistochemical staining, etc.
6. ECOG preformance status (PS.): 0-3
7. Study treatment is the first or second line chemotherapy* in inoperable metastatic breast cancer
*Endocrine therapy not included
8. Sufficient bone marrow and major organ functions (determined by the attending physician).
9. Written informed consent
Key exclusion criteria
1.History of hypersensitivity to the components of bevacizumab and paclitaxel
2.Hypersensitivity to preparations containing polyoxyethylene castor oil
3.History of hemoptysis (hemoptysis of fresh blood of more than 2.5 ml)
4.Complications of infection
5.Women who are pregnant, lactating or declined contraception
6.Under treatment with administration of disulfiram, cyanamide, carmofur or procarbazine hydrochloride
7.Symptomatic brain metastases
8.Uncontrolled hypertension
9.Arterial thromboembolism (stroke, myocardial infarction, etc.)
10.Venous thromboembolism (deep vein thrombosis, pulmonary embolism)
11.Urine protein over 2+
12.Gastrointestinal perforation and severe fistula
13.Patients considered ineligible by the attending physician
Target sample size
750
Research contact person
Name of lead principal investigator
| 1st name | 1)Yutaka, 2)Hiroyasu |
| Middle name | |
| Last name | 1)Yamamoto, 2)Yamashiro |
Organization
1) Kumamoto University Hospital
2) Tenri Hospital
Division name
1)Department of breast and endocrine surgery, 2) Department of breast surgery
Zip code
860-8556
Address
1)1-1-1 honjo, chuoku, kumamoto-city Kumamoto,Japan
TEL
096-373-5521
ys-yama@triton.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Jun |
| Middle name | |
| Last name | Fukase |
Organization
Japan Breast Cancer Research Group (JBCRG)
Division name
Head office
Zip code
103-0016
Address
9-4-3F, Nihonbashikoamicho, Chuo-ku, Tokyo 103-0016, Japan
TEL
03-6264-8873
Homepage URL
https://www.jbcrg.jp/
office@jbcrg.jp
Sponsor or person
Institute
1)Japan Breast Cancer Research Group (JBCRG)
2)Chugai Pharmaceutical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Chugai Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
Japan Breast Cancer Research Group (JBCRG)
IRB Contact (For public release)
Organization
N/A
Address
N/A
Tel
N/A
N/A
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 10 | Month | 12 | Day |
Related information
URL releasing protocol
https://upload.umin.ac.jp/cgi-bin/ctr/ctr_up_reg_f5.cgi
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1007/s12282-020-01138-4
Number of participants that the trial has enrolled
767
Results
Results:
Effectiveness was analyzed in 754 eligible patients (cohort A, 539; cohort B, 215) and safety in 750 treated patients. Median OS (95% CI) was 21.7 (19.8-23.6) months in eligible patients; 25.2 (22.4-27.4)
months and 13.2 (11.3-16.6) months in cohorts A and B, respectively.
Conclusion:
In Japanese clinical practice, combined bevacizumab-paclitaxel was as effective as in previous studies.
Results date posted
| 2021 | Year | 08 | Month | 18 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 07 | Month | 26 | Day |
Baseline Characteristics
HER2-negative LA/mBC　with confirmed HR status and no history of second-line chemotherapy for LA/mBC
Participant flow
Patients were enrolled through central registration and
classified by HR status: cohort A comprised patients with
HR-positive breast cancer, and cohort B, those with triplenegative breast cancer (TNBC).
Adverse events
Incidences of grade >= 3 AEs hypertension, neutropenia, peripheral neuropathy, proteinuria, and bleeding were 35.7%, 27.2%,
7.2%, 3.7%, and 0.3%, respectively.
Outcome measures
Primary endpoint:
Overall survival
Secondary endpoint:
Clinical response, PFS, Safety
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2012 | Year | 09 | Month | 27 | Day |
Date of IRB
| 2012 | Year | 09 | Month | 27 | Day |
Anticipated trial start date
| 2012 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observation & survey schedule
Management information
Registered date
| 2012 | Year | 10 | Month | 11 | Day |
Last modified on
| 2021 | Year | 08 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010278
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
